JP6043627B2 - アルブミン非含有ボツリヌス毒素製剤 - Google Patents

アルブミン非含有ボツリヌス毒素製剤 Download PDF

Info

Publication number
JP6043627B2
JP6043627B2 JP2012517802A JP2012517802A JP6043627B2 JP 6043627 B2 JP6043627 B2 JP 6043627B2 JP 2012517802 A JP2012517802 A JP 2012517802A JP 2012517802 A JP2012517802 A JP 2012517802A JP 6043627 B2 JP6043627 B2 JP 6043627B2
Authority
JP
Japan
Prior art keywords
botulinum toxin
liquid composition
positively charged
gly
lyophilizate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
JP2012517802A
Other languages
English (en)
Japanese (ja)
Other versions
JP2012531442A (ja
JP2012531442A5 (ko
Inventor
スチュアート エイ． トンプソン
スチュアート エイ． トンプソン
カーチス エル． リュエッグ
カーチス エル． リュエッグ
ジェイコブ エム． ウォー
ジェイコブ エム． ウォー
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Revance Therapeuticals Inc
Original Assignee
Revance Therapeuticals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Revance Therapeuticals Inc filed Critical Revance Therapeuticals Inc
Publication of JP2012531442A publication Critical patent/JP2012531442A/ja
Publication of JP2012531442A5 publication Critical patent/JP2012531442A5/ja
Application granted granted Critical
Publication of JP6043627B2 publication Critical patent/JP6043627B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/08—Clostridium, e.g. Clostridium tetani
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0216—Solid or semisolid forms
    • A61K8/022—Powders; Compacted Powders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/494—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with more than one nitrogen as the only hetero atom
    • A61K8/4946—Imidazoles or their condensed derivatives, e.g. benzimidazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4973—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4993—Derivatives containing from 2 to 10 oxyalkylene groups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/60—Sugars; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/60—Sugars; Derivatives thereof
    • A61K8/602—Glycosides, e.g. rutin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A61K8/66—Enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/90—Block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/99—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from microorganisms other than algae or fungi, e.g. protozoa or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/10—Anti-acne agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/008—Preparations for oily skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Clostridium (G)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
    • C12Y304/24069—Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
JP2012517802A 2009-06-25 2010-06-25 アルブミン非含有ボツリヌス毒素製剤 Expired - Fee Related JP6043627B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US22043309P 2009-06-25 2009-06-25
US61/220,433 2009-06-25
PCT/US2010/040104 WO2010151840A2 (en) 2009-06-25 2010-06-25 Albumin-free botulinum toxin formulations

Publications (3)

Publication Number Publication Date
JP2012531442A JP2012531442A (ja) 2012-12-10
JP2012531442A5 JP2012531442A5 (ko) 2013-08-08
JP6043627B2 true JP6043627B2 (ja) 2016-12-14

Family

ID=43381023

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2012517802A Expired - Fee Related JP6043627B2 (ja) 2009-06-25 2010-06-25 アルブミン非含有ボツリヌス毒素製剤

Country Status (13)

Country Link
US (5) US20120107361A1 (ko)
EP (1) EP2445521A4 (ko)
JP (1) JP6043627B2 (ko)
KR (5) KR101804279B1 (ko)
CN (1) CN102869373B (ko)
AU (1) AU2010265888A1 (ko)
BR (1) BRPI1015938A2 (ko)
CA (1) CA2766521C (ko)
CO (1) CO6491076A2 (ko)
IL (2) IL268980B (ko)
MX (3) MX366344B (ko)
SG (1) SG177357A1 (ko)
WO (1) WO2010151840A2 (ko)

Families Citing this family (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9211248B2 (en) 2004-03-03 2015-12-15 Revance Therapeutics, Inc. Compositions and methods for topical application and transdermal delivery of botulinum toxins
WO2005120546A2 (en) 2004-03-03 2005-12-22 Essentia Biosystems, Inc. Compositions and methods for topical diagnostic and therapeutic transport
US7879341B2 (en) * 2004-07-26 2011-02-01 Merz Pharma Gmbh & Co. Kgaa Therapeutic composition with a botulinum neurotoxin
JP2008531732A (ja) 2005-03-03 2008-08-14 ルバンス セラピュティックス インク． ボツリヌス毒素の局所塗布及び経皮送達のための組成物及び方法
US8168206B1 (en) 2005-10-06 2012-05-01 Allergan, Inc. Animal protein-free pharmaceutical compositions
PL2379104T3 (pl) 2008-12-31 2018-07-31 Revance Therapeutics, Inc. Preparaty toksyny botulinowej do wstrzykiwania
BRPI1015938A2 (pt) * 2009-06-25 2016-09-27 Revance Therapeutics Inc formulações da toxina botulínica livre de albumina
PT2490986T (pt) * 2009-10-21 2018-11-13 Revance Therapeutics Inc Métodos e sistemas para purificar neurotoxina botulínica não complexada
US20120294844A1 (en) * 2011-01-07 2012-11-22 Revance Therapeutics, Inc. Methods And Kits For Topical Application, Removal, And Inactivation Of Therapeutic Or Cosmetic Toxin Compositions
WO2013142755A1 (en) 2012-03-22 2013-09-26 Revance Therapeutics, Inc. Method of treatment of wrinkles using topical chemodenervating agents
US20140242110A1 (en) * 2013-02-28 2014-08-28 Dt Scimed, Llc Dose, localization, and formulation of botulinum toxins in skin and muscle
RU2662968C2 (ru) * 2013-09-08 2018-07-31 Пфайзер Инк. Иммуногенная композиция против neisseria meningitidis (варианты)
US9480731B2 (en) 2013-12-12 2016-11-01 Medy-Tox, Inc. Long lasting effect of new botulinum toxin formulations
CA2947006A1 (en) * 2014-04-30 2015-11-05 Eric A. Forssen Formulations of biologics for intravesical instillation
SG11201705019PA (en) * 2014-12-23 2017-07-28 Merz Pharma Gmbh & Co Kgaa Botulinum toxin prefilled container
BR112017016759B1 (pt) * 2015-02-03 2021-01-12 Merz Pharma Gmbh & Co. Kgaa seringa de plástico pré-carregada, kit, uso da seringa de plástico pré-carregada e método para o tratamento cosmético da pele
CN109069608A (zh) * 2015-10-29 2018-12-21 雷文斯治疗公司 具有长的治疗或美容效应持续时间的可注射肉毒杆菌毒素制剂以及其使用方法
WO2018038585A1 (ko) * 2016-08-26 2018-03-01 주식회사 에이비바이오 보툴리눔 독소 및 안정화제를 포함하는 액상 제형 및 이의 제조방법
WO2018038301A1 (en) * 2016-08-26 2018-03-01 Hugel Inc. Stabilized liquid formulation of botulinum toxin and preparation method thereof
ES2755815T3 (es) * 2016-09-13 2020-04-23 Allergan Inc Composiciones de toxina de Clostridium no proteicas estabilizadas
AU2017360346B2 (en) * 2016-11-21 2023-11-23 Eirion Therapeutics, Inc. Transdermal delivery of large agents
KR101744900B1 (ko) * 2017-01-20 2017-06-08 주식회사 대웅 보툴리눔 독소를 포함하는 안정한 액상 조성물
EP3624819A4 (en) * 2017-05-18 2021-03-24 Revance Therapeutics, Inc. METHOD OF TREATMENT OF CERVICAL DYSTONIA
CA3068292A1 (en) * 2017-06-26 2019-01-03 Bonti, Inc. Clostridial neurotoxin formulations and use
US20210162026A1 (en) 2017-08-28 2021-06-03 Revance Therapeutics, Inc. Transmucosal botulinum toxin compositions, kits, and methods for treating bladder disorders
KR102063475B1 (ko) * 2018-02-22 2020-01-09 주식회사 에이비바이오 보툴리눔 독소, 안정화제, 및 국소마취제를 포함하는 액상 제형 및 이의 제조방법
KR102324855B1 (ko) * 2020-05-20 2021-11-11 오스템임플란트 주식회사 보툴리눔 독소를 포함하는 약제학적 액상 조성물
KR102414997B1 (ko) * 2020-09-29 2022-06-29 주식회사 엘지생활건강 안정성이 개선된 재조합 보툴리눔 독소 경쇄 단백질 조성물
CA3194375A1 (en) * 2020-10-07 2022-04-14 Hak Kun Kim Vacuum drying method for botulinum toxin
US20240050538A1 (en) * 2020-12-18 2024-02-15 Atgc Co., Ltd. Pharmaceutical composition for long-term storage of liquid formulation of botulinum toxin
KR102427362B1 (ko) * 2021-11-11 2022-08-01 (주)이니바이오 보툴리눔 독소 제제의 건조 공정

Family Cites Families (86)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5804604A (en) 1989-12-21 1998-09-08 Biogen, Inc. Tat-derived transport polypeptides and fusion proteins
JP3905921B2 (ja) 1992-10-02 2007-04-18 ジェネティクス インスチチュート リミテッド ライアビリティー カンパニー 凝固第▲ｖｉｉｉ▼因子を含む組成物及びその製造方法並びに安定剤としての界面活性剤の使用方法
EP0737074B1 (en) 1993-12-28 2001-08-01 Allergan Sales, Inc. Botulinum toxins for treating hyperhydrosis
US5756468A (en) 1994-10-13 1998-05-26 Wisconsin Alumni Research Foundation Pharmaceutical compositions of botulinum toxin or botulinum neurotoxin and methods of preparation
US5512547A (en) 1994-10-13 1996-04-30 Wisconsin Alumni Research Foundation Pharmaceutical composition of botulinum neurotoxin and method of preparation
GB9508204D0 (en) 1995-04-21 1995-06-07 Speywood Lab Ltd A novel agent able to modify peripheral afferent function
US20030095927A1 (en) 1997-10-01 2003-05-22 Dugger Harry A. Buccal, polar and non-polar spray or capsule containing drugs for treating muscular and skeletal disorders
JP2002501033A (ja) 1998-01-26 2002-01-15 ユニバーシティー オブ マサチューセッツ Ａ型ボツリヌス菌の生物学的活性赤血球凝集素とその使用法
TW574036B (en) 1998-09-11 2004-02-01 Elan Pharm Inc Stable liquid compositions of botulinum toxin
US6358917B1 (en) * 1999-08-24 2002-03-19 Jean D. A. Carruthers Cosmetic use of botulinum toxin for treatment of downturned mouth
US6544548B1 (en) * 1999-09-13 2003-04-08 Keraplast Technologies, Ltd. Keratin-based powders and hydrogel for pharmaceutical applications
US6844324B1 (en) * 1999-11-12 2005-01-18 Massachusetts Institute Of Technology Modular peptide mediated intracellular delivery system and uses therefore
IL149778A0 (en) 1999-11-22 2002-11-10 Universal Preservation Technologies Inc Preservation of sensitive biological material
US7780967B2 (en) 2000-02-08 2010-08-24 Allergan, Inc. Reduced toxicity Clostridial toxin pharmaceutical compositions
US20030118598A1 (en) * 2000-02-08 2003-06-26 Allergan, Inc. Clostridial toxin pharmaceutical compositions
NZ520201A (en) 2000-02-08 2004-04-30 Allergan Inc Botulinum toxin pharmaceutical compositions comprising a polysaccharide
US6670322B2 (en) * 2000-06-01 2003-12-30 Wisconsin Alumni Research Foundation Method of targeting pharmaceuticals to motor neurons
US20040033241A1 (en) 2000-06-02 2004-02-19 Allergan, Inc. Controlled release botulinum toxin system
US6306423B1 (en) 2000-06-02 2001-10-23 Allergan Sales, Inc. Neurotoxin implant
US20040220100A1 (en) 2000-07-21 2004-11-04 Essentia Biosystems, Inc. Multi-component biological transport systems
DK1301213T3 (en) * 2000-07-21 2017-03-27 Revance Therapeutics Inc MULTI-COMPONENT SYSTEMS FOR BIOLOGICAL TRANSPORT
US6787517B1 (en) * 2000-12-29 2004-09-07 Allergan, Inc. Agent and methods for treating pain
US20020197278A1 (en) 2001-06-21 2002-12-26 Surromed, Inc. Covalent coupling of botulinum toxin with polyethylene glycol
KR101080021B1 (ko) * 2002-02-14 2011-11-04 추가이 세이야쿠 가부시키가이샤 항체함유 용액제제
AU2003231878A1 (en) 2002-05-31 2003-12-19 Solux Corporation Pharmaceutical preparation of botulinum neurotoxin, methods of synthesis and methods of clinical use
US20040009180A1 (en) 2002-07-11 2004-01-15 Allergan, Inc. Transdermal botulinum toxin compositions
US9265725B2 (en) * 2002-10-25 2016-02-23 Foamix Pharmaceuticals Ltd. Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
US8119109B2 (en) * 2002-10-25 2012-02-21 Foamix Ltd. Foamable compositions, kits and methods for hyperhidrosis
RU2206337C1 (ru) 2002-10-29 2003-06-20 Общество с ограниченной ответственностью "Токсины и сопутствующие продукты" Лекарственный препарат для лечения мышечных дистоний и способ его получения
US20040086532A1 (en) 2002-11-05 2004-05-06 Allergan, Inc., Botulinum toxin formulations for oral administration
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
US20100266638A1 (en) * 2004-02-26 2010-10-21 Allergan, Inc. Headache treatment method
US9211248B2 (en) * 2004-03-03 2015-12-15 Revance Therapeutics, Inc. Compositions and methods for topical application and transdermal delivery of botulinum toxins
LT2985039T (lt) * 2004-03-03 2018-11-12 Revance Therapeutics, Inc. Botulino toksinų vietinis taikymas ir jų įvedimas per odą
WO2005120546A2 (en) * 2004-03-03 2005-12-22 Essentia Biosystems, Inc. Compositions and methods for topical diagnostic and therapeutic transport
GB2416122A (en) * 2004-07-12 2006-01-18 Ipsen Ltd Botulinum neurotoxin composition
US7879341B2 (en) 2004-07-26 2011-02-01 Merz Pharma Gmbh & Co. Kgaa Therapeutic composition with a botulinum neurotoxin
US20070196364A1 (en) * 2004-07-27 2007-08-23 Human Genome Sciences, Inc. Pharmaceutical Formulation and Process
WO2006013370A1 (en) 2004-08-04 2006-02-09 Ipsen Limited Pharmaceutical composition containing botulinum neurotoxin a2
EP2813239B1 (en) * 2004-08-04 2017-03-22 Ipsen Biopharm Limited Pharmaceutical composition containing botulinum neurotoxin A2
GB2419526A (en) 2004-10-28 2006-05-03 Ipsen Ltd Pharmaceutical composition containing botulinum neurotoxin
US7838011B2 (en) * 2005-02-14 2010-11-23 Pankaj Modi Stabilized protein compositions for topical administration and methods of making same
US9314431B2 (en) * 2005-02-14 2016-04-19 Transdermal Corp Solubilized benzoyl small molecule
US7727537B2 (en) * 2005-02-14 2010-06-01 Dpm Therapeutics Corp. Stabilized compositions for topical administration and methods of making same
JP2008531732A (ja) * 2005-03-03 2008-08-14 ルバンス セラピュティックス インク． ボツリヌス毒素の局所塗布及び経皮送達のための組成物及び方法
US8323666B2 (en) * 2005-08-01 2012-12-04 Allergan, Inc. Botulinum toxin compositions
US8168206B1 (en) 2005-10-06 2012-05-01 Allergan, Inc. Animal protein-free pharmaceutical compositions
US8137677B2 (en) 2005-10-06 2012-03-20 Allergan, Inc. Non-protein stabilized clostridial toxin pharmaceutical compositions
WO2007059528A2 (en) * 2005-11-17 2007-05-24 Revance Therapeutics, Inc. Compositions and methods of topical application and transdermal delivery of botulinum toxins with reduced non-toxin proteins
US9486408B2 (en) * 2005-12-01 2016-11-08 University Of Massachusetts Lowell Botulinum nanoemulsions
US7899450B2 (en) * 2006-03-01 2011-03-01 Telecommunication Systems, Inc. Cellular augmented radar/laser detection using local mobile network within cellular network
US20090123527A1 (en) * 2006-07-24 2009-05-14 Akorn, Inc. Method of inducing topical anesthesia and transdermal patch
EP2068834A2 (en) * 2006-09-08 2009-06-17 Becton, Dickinson & Company Stable powder formulations of aluma-dsorbed vaccines
AU2007329579A1 (en) * 2006-12-01 2008-06-12 Anterios, Inc. Amphiphilic entity nanoparticles
AU2007234612B2 (en) * 2006-12-14 2013-06-27 Johnson & Johnson Regenerative Therapeutics, Llc Protein stabilization formulations
FR2910327B1 (fr) * 2006-12-22 2013-04-26 Scras Utilisation d'au moins une neurotoxine botulique pour traiter la douleur induite par les traitements therapeutiques du virus du sida.
KR20090096735A (ko) * 2006-12-29 2009-09-14 레반스 테라퓨틱스, 아이엔씨. Ｈｉｖ-ｔａｔ로부터 유래된 폴리펩티드 단편에 의해 안정화된 보툴리눔 독소의 국소 적용 및 경피 전달용 조성물 및 방법
GB0700523D0 (en) * 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
KR20100020972A (ko) * 2007-06-01 2010-02-23 메르츠 파마 게엠베하 운트 코. 카가아 보툴리늄 톡신의 신경독 성분에 기초한 온도-안정한 근육 이완제를 제공하는 방법
KR101087017B1 (ko) * 2007-07-10 2011-12-09 (주)메디톡스 보툴리눔 독소의 안정성이 개선된 약제학적 액상 조성물
HUE031136T2 (en) * 2007-07-26 2017-07-28 Revance Therapeutics Inc Antimicrobial peptide and preparations
WO2009056651A1 (en) * 2007-11-02 2009-05-07 Cytos Biotechnology Ag Angiotensin-carrier formulation
US9107815B2 (en) * 2008-02-22 2015-08-18 Allergan, Inc. Sustained release poloxamer containing pharmaceutical compositions
RU2535003C2 (ru) 2008-12-10 2014-12-10 Аллерган, Инк. Фармацевтические композиции токсина клостридий
PL2379104T3 (pl) * 2008-12-31 2018-07-31 Revance Therapeutics, Inc. Preparaty toksyny botulinowej do wstrzykiwania
EP2248518B1 (en) * 2009-04-17 2013-01-16 Merz Pharma GmbH & Co. KGaA Formulation for stabilizing proteins, peptides or mixtures thereof.
BRPI1015938A2 (pt) * 2009-06-25 2016-09-27 Revance Therapeutics Inc formulações da toxina botulínica livre de albumina
US9849173B2 (en) * 2009-07-06 2017-12-26 Variation Biotechnologies Inc. Methods for preparing vesicles and formulations produced therefrom
WO2011028962A1 (en) * 2009-09-04 2011-03-10 Xoma Technology Ltd. Antibody coformulations
PT2490986T (pt) * 2009-10-21 2018-11-13 Revance Therapeutics Inc Métodos e sistemas para purificar neurotoxina botulínica não complexada
AU2010313529A1 (en) * 2009-10-30 2012-04-12 Duoject Medical Systems, Inc. Device and method for topical application of therapeutics or cosmetic compositions
JP5788399B2 (ja) * 2009-10-30 2015-09-30 デュオジェクト・メディカル・システムズ・インコーポレイテッド インターバイアル移送システム
AU2011316111B2 (en) * 2010-10-12 2015-05-28 Merz Pharma Gmbh & Co. Kgaa Formulation suitable for stabilizing proteins, which is free of mammalian excipients
US20120294844A1 (en) * 2011-01-07 2012-11-22 Revance Therapeutics, Inc. Methods And Kits For Topical Application, Removal, And Inactivation Of Therapeutic Or Cosmetic Toxin Compositions
RU2640922C1 (ru) * 2011-03-31 2018-01-12 Меди-Токс Инк. Лиофилизированный препарат ботулотоксина
WO2013130535A1 (en) * 2012-02-27 2013-09-06 Newgen Biopharma Corporation Topical delivery of hormonal and non hormonal nano formulations, methods of making and using the same
MX370929B (es) * 2012-10-28 2020-01-08 Revance Therapeutics Inc Composiciones y usos de las mismas para el tratamiento seguro de la rinitis.
GB201407525D0 (en) * 2014-04-29 2014-06-11 Syntaxin Ltd Manufacture of recombinant clostridium botulinum neurotoxins
SG11201705019PA (en) 2014-12-23 2017-07-28 Merz Pharma Gmbh & Co Kgaa Botulinum toxin prefilled container
CN109069608A (zh) * 2015-10-29 2018-12-21 雷文斯治疗公司 具有长的治疗或美容效应持续时间的可注射肉毒杆菌毒素制剂以及其使用方法
FI126979B (en) * 2016-02-29 2017-09-15 Faron Pharmaceuticals Oy Lyophilized pharmaceutical formulation and use thereof
JP2019513799A (ja) * 2016-04-12 2019-05-30 イラストリス ファーマシューティカルズ、インク． 化合物の局所適用を目的とした組成物
EP3463432B1 (en) 2016-05-27 2020-10-07 Ipsen Biopharm Limited Liquid neurotoxin formulation stabilized with tryptophan or tyrosine
US20210162026A1 (en) * 2017-08-28 2021-06-03 Revance Therapeutics, Inc. Transmucosal botulinum toxin compositions, kits, and methods for treating bladder disorders
AU2018359962A1 (en) * 2017-11-03 2020-05-28 Revance Therapeutics, Inc. Botulinum toxin formulations and methods of use thereof in plantar fasciitis with extended duration of effect
KR20200105829A (ko) * 2017-12-04 2020-09-09 레반스 테라퓨틱스, 아이엔씨. 주사 가능한 보툴리눔 독소 제제 및 높은 반응 속도 및 긴 효과 지속을 갖는 이의 사용 방법

Also Published As

Publication number Publication date
KR101975051B1 (ko) 2019-05-03
KR102328155B1 (ko) 2021-11-17
MX366344B (es) 2019-07-05
US20100330123A1 (en) 2010-12-30
WO2010151840A3 (en) 2014-03-20
CO6491076A2 (es) 2012-07-31
KR20190047736A (ko) 2019-05-08
JP2012531442A (ja) 2012-12-10
KR20200141546A (ko) 2020-12-18
US11351232B2 (en) 2022-06-07
KR20170133530A (ko) 2017-12-05
US20210330766A1 (en) 2021-10-28
EP2445521A4 (en) 2015-08-26
CA2766521A1 (en) 2010-12-29
US20190290740A1 (en) 2019-09-26
EP2445521A2 (en) 2012-05-02
MX2012000174A (es) 2012-05-23
KR20120102569A (ko) 2012-09-18
KR102192618B1 (ko) 2020-12-17
IL268980A (en) 2019-10-31
WO2010151840A2 (en) 2010-12-29
MX2019008126A (es) 2019-09-09
KR20210141783A (ko) 2021-11-23
MX344583B (es) 2016-12-20
KR101804279B1 (ko) 2017-12-05
IL217156A0 (en) 2012-02-29
SG177357A1 (en) 2012-02-28
US9340587B2 (en) 2016-05-17
CN102869373A (zh) 2013-01-09
US20120107361A1 (en) 2012-05-03
US11911449B2 (en) 2024-02-27
BRPI1015938A2 (pt) 2016-09-27
IL268980B (en) 2022-09-01
AU2010265888A1 (en) 2012-01-19
US20160256532A1 (en) 2016-09-08
CN102869373B (zh) 2017-05-10
CA2766521C (en) 2020-07-21
US10111939B2 (en) 2018-10-30

Similar Documents

Publication Publication Date Title
JP6043627B2 (ja) アルブミン非含有ボツリヌス毒素製剤
JP6559849B2 (ja) 注射用ボツリヌス毒素製剤
US20120148562A1 (en) Methods and compositions for treating skin conditions associated with vascular hyper-reactivity
US20220096610A1 (en) Methods of treatment for cervical dystonia
CA3195483A1 (en) Methods for treating cervical dystonia

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20130618

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20130618

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20140710

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20141006

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20141014

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20141104

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20141111

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20141128

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20141205

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20150113

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20150730

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20151026

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20160317

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20160613

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20160804

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160920

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20161013

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20161114

R150 Certificate of patent or registration of utility model

Ref document number: 6043627

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

LAPS Cancellation because of no payment of annual fees